MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550350-33
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure performed was to treat a left main coronary artery.A 3.50x33mm xience sierra was noted to be slow during inflation; however, stent was deployed at 18 atmospheres.The xience sierra would not fully deflate after attempts to flush the contrast out of the balloon with saline, pulled negative multiple times and finally resorted to using the phillips laser to pop and deflate the balloon.It was noted the device was not prepped (air aspiration) outside the anatomy prior to use.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
It was reported that the procedure performed was to treat a right coronary artery.A 3.50x33mm xience sierra was noted to be slow during inflation; however, stent was deployed at 18 atmospheres.The xience sierra would not fully deflate after attempts to flush the contrast out of the balloon with saline, pulled negative multiple times and finally resorted to using the phillips laser to pop and deflate the balloon.It was noted the device was not prepped (air aspiration) outside the anatomy prior to use.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.B5 correction: whether or not the balloon suddenly deflated on its own or was ruptured by the laser is unknown, but it eventually did deflate without causing any harm to the patient or to the stent itself.
Additional Manufacturer Narrative
2017- above rbp.The device was returned for analysis.The reported inflation problem and the reported deflation problem were unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Reportedly, the device was not prepped (air aspiration) outside the anatomy prior to use.It should be noted that the xience sierra everolimus eluting coronary stent system instructions for use (ifu) lists delivery system preparation to be performed prior to delivery procedure.Additionally, it was reported the stent was deployed at 18 atmospheres (atm).It should be noted that the instructions for use states: note: do not exceed the labeled rated burst pressure (rbp).A cine was received and reviewed by an abbott vascular clinical specialist.The provided images are for the treatment of a right coronary artery.However, a stent appearing to be 3.50x33mm in size is deployed in the proximal right coronary artery and the balloon of the stent delivery system does fail to deflate completely.As several images focus on the balloon failing to deflate in the right coronary artery it is reasonable to conclude that this is the device in question.There are no images of a laser catheter being used to ¿pop¿ the balloon.As the reported difficulties inflating and deflating the balloon were unable to be confirmed during return analysis, the investigation determined a conclusive cause for the reported inflation/deflation issues cannot be determined.The noted multiple bends on the hypotube likely occurred due to handling during/post procedure or during packing for return analysis.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11095202
• Report Number: 2024168-2020-11005
• Device Sequence Number: 16355276
• Product Code: NIQ
• UDI-Device Identifier: 08717648227455
• UDI-Public: 08717648227455
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: 1550350-33
• Device Catalogue Number: 1550350-33
• Device Lot Number: 0051141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR